LifeSiteNews.com

FDA Approves Dangerous ‘Ella’ Abortion Drug as Contraception

LifeSiteNews.com
LifeSiteNews.com

By Peter J. Smith

WASHINGTON, D.C., August 13, 2010 (LifeSiteNews.com) –  The U.S. Food & Drug Administration (FDA) approved Friday afternoon HRA Pharma’s “ella,” a new drug billed as an advanced form of "emergency contraception," for sale and distribution in the United States. However, pro-life advocates have raised the alarm on the drug’s safety and testing, and say ella is little more than a chemical abortion drug similar to RU-486, remarketed to the public as contraception. 

The FDA’s unanimous decision allows the drug to be marketed in the United States as an “occasional” emergency contraception, taken by a woman up to five days after sexual intercourse. The FDA warned, however, that it was unsafe for women to use ella more than occasionally, as they had no data on its safety over the long term. They also warned that women should be ruled out as pregnant before being prescribed ella, and women experiencing lower abdominal pain or who become pregnant after taking ella should be checked by their health care providers for ectopic pregnancy. (see release)

Pro-life leaders, however, were upset with the federal regulatory agency’s decision to approve the drug, pointing out that ella chemically works the same as RU-486. Therefore it not only can cause an abortion, but may also pose a risk to a woman’s health and life, and even have an adverse effect on later pregnancies. 

“The FDA underscored the point that this decision was driven by politics by releasing it late on a Friday when people are not paying attention,” said Wendy Wright, President of Concerned Women for America. “The meager trials done on ella indicate it may cause miscarriages and birth defects. Yet the FDA allowed the HRA Pharma to avoid fully testing the drug so women will be kept in the dark on what kind of serious complications it may cause to her and her baby.”

The chemical name for ella is ulipristal acetate, which functions as a progestin-blocker, or "selective progesterone receptor modulator (SPRM)."

Other forms of emergency contraception work by releasing massive amounts of progesterone into a woman's body, thereby suppressing ovulation, inhibiting sperm migration and reducing sperm capacity for fertilization. This can also have an abortifacient effect if the influx of progesterone changes the lining of the womb, preventing an already conceived embryo from implanting.

But ulipristal acetate works far differently, with far more effective abortifacient results. As a SPRM, it turns off the progesterone receptors in the body crucial not only for the beginning of pregnancy, but its continuance.

Mifeprostone, the drug taken in the two step RU-486 regimen, is also a SPRM, which also has been found to have had thousands of "adverse event reports" related to its use. Since the FDA approved it for sale in 2000, Mifepristone has been tied to 13 confirmed deaths, 9 of which were reported in the U.S. As of May 2006, when the FDA began reporting cases of women suffering from adverse effects of RU-486, 1,070 events were recorded, including six deaths, 9 life-threatening incidents, 232 hospitalizations, 116 blood transfusions, and 88 cases of infection. 

Wright added that the best regulatory defense for women may be trial lawyers: the FDA, she said, appears to hold reproductive drugs to a lower standard than other drugs, and “treats serious complications and even death as preferable to pregnancy.”

“Make no mistake about it, ella is a dangerous abortion drug,” said Kristan Hawkins, Executive Director of Students for Life of America, in a statement calling upon the FDA to review and reverse its decision. “The FDA’s approval of ella for sale within the U.S. shows that the FDA has not done its job protecting women, particularly young women whom SFLA serves on a daily basis.” 
Students for Life of America and the “ella Causes Abortions Coalition” released a video Friday afternoon highlighting their concerns with ella’s possible effects and other questions unanswered by HRA Pharma. 

Unfortunately, little data currently exists to answer these questions. Ulipristal acetate was studied by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), but they admitted they lacked any concrete information as to the effects of the drug on women who do get pregnant. In 29 cases of women who became pregnant while testing ulipristal, 16 chose to have an induced abortion, six miscarried, another six said they were going to carry their babies to term, but they received no information regarding the status of their pregnancies.

But the labeling of ella as an emergency contraceptive, rather than an early abortion-inducing drug, may actually have another financial motive for HRA Pharma: the U.S. federal government may end up its biggest single customer. 

“By misclassifying ella as emergency contraception, this administration has paved the way to covertly allow federal funding for abortion through Medicaid, Title X, and international family planning programs,” said U.S. Rep. Chris Smith (R-N.J.), co-chairman of the bipartisan Congressional Pro-Life Caucus. Given President Barack Obama’s ideological commitment to abortion, said Smith, it was no surprise.

The congressman urged another Executive Order from President Obama preventing the federal government from funding ella or forcing insurance companies to cover it as an essential benefit. 

“The FDA is supposed to protect people from dangerous drugs and deceptive marking. Instead, today they have proven they are willing to be complicit in this abortion cover-up,” said Smith.

“At a minimum the drug should be classified as an abortion drug.  Women deserve to know that these pills they believe prevent pregnancy could actually kill their unborn child by withholding vital nutrients and effectively starving the child to death.”
 
See related coverage by LifeSiteNews.com:

FDA Readies Public Hearing for Next Generation Abortion Drug
http://www.lifesitenews.com/ldn/2010/jun/10060211.html 

Pro-life blogger concerned after RU-486 abortion Tweeter goes silent 
http://www.lifesitenews.com/ldn/2010/mar/10031208.html

Oregon Planned Parenthood Offers RU-486 Abortion in 'Privacy of Their Home' 
http://www.lifesitenews.com/ldn/2010/feb/10022513.html

Planned Parenthood Implicated in RU-486 Deaths of Four Women 
http://www.lifesitenews.com/ldn/2008/jun/08061907.html

Leading Researcher Proves RU-486 Causes Septic Shock Deaths 
http://www.lifesitenews.com/ldn/2005/jul/05072802.html

Truth. Delivered daily.

Get FREE pro-life, pro-family news delivered straight to your inbox. 

Select Your Edition:


Share this article

Advertisement
Featured Image
Cardinal Raymond Burke, prefect of the Apostolic Signatura, speaks to Thomas McKenna of Catholic Action Insight. Catholic Action Insight
Hilary White Hilary White Follow Hilary

Catholics shouldn’t sue one another: Cardinal Burke comments on Fr. Rosica’s lawsuit against blogger

Hilary White Hilary White Follow Hilary
By Hilary White

ROME, March 2, 2015 (LifeSiteNews.com) – Citing Scripture, Cardinal Raymond Burke told an interviewer this week that Catholics should not sue each other: “Our Lord in the Gospel and St. Paul in his First Letter to the Corinthians instruct us not to take our disputes to the civil forum, that we should be able, as Catholics, to resolve these matters among ourselves.”

The cardinal’s comments to the Traditionalist Catholic website Rorate Caeli follow an uproar in the Catholic media world last week when it was revealed that Vatican spokesman Father Thomas Rosica has threatened to sue a Canadian blogger for defamation in the civil courts.

Cardinal Burke, who served under Pope Benedict XVI and Pope Francis as the head of the Vatican’s highest court, is a noted expert on canon law. He told Rorate Caeli, “Unless the blogger has committed a calumny on someone's good name unjustly, I certainly don't think that that's the way we as Catholics should deal with these matters.”

“I think contact should be made. I presume that the Catholic blogger is in good faith, and if there’s someone in the hierarchy who is upset with him, the way to deal with it would be first to approach the person directly and try to resolve the matter in that way,” Burke added.

Fr. Rosica, a Canadian Basilian, is the English language press officer for the Vatican and founder of the Toronto-based Salt and Light Television network.

He sent the legal letter to David Domet, a Toronto music composer and part-time Catholic blogger who has long criticized what he says are Fr. Rosica’s departures from Catholic orthodoxy. The priest’s lawyer told Domet to remove nine separate items from his blog and apologize, but added that this would not necessarily remove the threat of the civil action.

The conflict was covered in a feature by Michael Voris’ Church Militant TV, and the internet’s Catholic blogger world exploded with indignation. So furious was the backlash that it got coverage by the US conservative news site, Breitbart. This followed dozens of blog posts, nearly unanimously calling the threatened legal action of a well-placed priest against a lay pensioner a “PR disaster” for Rosica. 

The uproar has launched Domet’s small blog, Vox Cantoris, into the international limelight, and has earned Fr. Rosica an avalanche of criticism. “Though Rosica publicly defends the right to freedom of speech and press, he is attempting to silence the blogger who has criticized him,” Austin Ruse, president of the Catholic Family and Human Rights Institute, wrote for Breitbart.

Among Domet’s criticisms of Fr. Rosica is his apparent support for the proposal by Cardinal Walter Kasper to allow divorced and civilly remarried Catholics, and others in “irregular” sexual unions, to receive Holy Communion.

Fr. Rosica has also recently come under fire for comments he made a year ago, in a lecture in Windsor, Ontario, in which he argued that Catholic doctrine could change. (See video below. Quotes can be found at 48:12.)

“Will this Pope re-write controversial Church doctrines?” Fr. Rosica said in the lecture, which was posted to Youtube. “No. But that isn't how doctrine changes. Doctrine changes when pastoral contexts shift and new insights emerge such that particularly doctrinal formulations no longer mediate the saving message of God's transforming love.”

Fr. Rosica continued: “Doctrine changes when the Church has leaders and teachers who are not afraid to take note of new contexts and emerging insights. It changes when the Church has pastors who do what Francis has been insisting: leave the securities of your chanceries, of your rectories, of your safe places, of your episcopal residences go set aside the small-minded rules that often keep you locked up and shielded from the world.”

In the Rorate Caeli interview, Cardinal Burke refuted the idea that the Church can change its “pastoral practice” without changing doctrine.

“I think it’s very important to address a false dichotomy that's been drawn by some who say, ‘Oh no, we’re just changing disciplines. We’re not touching the Church's doctrine.’ But if you change the Church’s discipline with regard to access to Holy Communion by those who are living in adultery, then surely you are changing the Church's doctrine on adultery.”

“You’re saying that, in some circumstances, adultery is permissible and even good, if people can live in adultery and still receive the sacraments. That is a very serious matter, and Catholics have to insist that the Church’s discipline not be changed in some way which would, in fact, weaken our teaching on one of the most fundamental truths, the truth about marriage and the family,” Cardinal Burke said.

Fr. Rosica recently criticized Cardinal Burke on his Twitter account by posting an article by Washington, DC’s Cardinal Donald Wuerl on “dissent” in the hierarchy, saying, “Cardinal Wuerl’s response to Burke (and dissenters).”

The priest has also had a confrontational relationship with the pro-life movement for years.

In 1996, Fr. Rosica called the police on pro-life advocates who were leafletting in protest at a lecture by famous dissident Gregory Baum at the University of Toronto’s Newman Centre.

In 2009, Fr. Rosica wrote against objections to the lavish Catholic funeral for US Senator Ted Kennedy’s in Boston. He excoriated the pro-life movement for what he called their lack of “civility.”

“Civility, charity, mercy and politeness seem to have dropped out of the pro-life lexicon,” Fr. Rosica wrote. “To recognize and bring out the sin in others means also recognizing one’s self as a sinner and in need of God’s boundless mercy.

“Let us pray that we will become more and more a people, a church and a community overflowing with mercy.”

Share this article

Advertisement
Featured Image
Greg Rohrbough, J.D.

Duck Commander Phil Robertson’s CPAC speech was viral in so many ways

Greg Rohrbough, J.D.
By

Last week, the winner of the 2015 Citizens United/CPAC Andrew Breitbart Defender of the First Amendment Award was “Duck Commander” Phil Robertson, paterfamilias of the Duck Dynasty Robertson family. In doing so, they were giving Phil the CPAC stage for a speech, knowing that he would speak his unvarnished thoughts. One doubts they expected his topic.

After bringing out his heavily-duct-taped Bible and telling politicians to keep theirs with them, Phil went on the offensive – against sexually transmitted diseases (STDs). He quoted the federal Centers for Disease Control, which estimates that more than 100 million Americans now have a sexually transmitted infection.

“I don’t want you to become ill. I don’t want you to come down with a debilitating disease. I don’t want you to die early,” Robertson said.

Phil’s solution? One older than Christianity, as old as common sense itself. “If you’re disease-free, if she’s disease-free, you marry. You keep your sex right there. You won’t get sick from a sexually-transmitted disease!”

Logic and mathematics would seem to agree. According to Robertson, his goal was to show love to the listeners. But several left-wing websites didn’t see it that way.

“He certainly used his speech to hate very well. I guess that's the criteria. Who can say the sickest, most vile things about center-left Americans wins!” according to John Amato of Crooks & Liars.

The Huffington Post took offense at his attributing the rise in STDs to the beatniks and hippies.

To their credit, MSNBC acknowledged Phil’s numbers, saying, “For the record, Robertson’s [sic] has his numbers correct. A CDC report from February of 2013 estimated more than 110 [million] cases of sexually transmitted infections in America with about 20 billion [sic, MSNBC’s number] new infections each year at a cost of ‘nearly $16 billion in direct medical costs.’”

The network site then blasted him for comparing ISIS to the Nazis, Communists, and Imperial Japanese.

Click "like" if you want to defend true marriage.

Robertson clearly didn’t care what MSNBC thought, though. “You want a Godly, Biblical, medically safe option? One man, one woman, married, for life,” he said.

“What do you call the 110 million people who have sexually transmitted illnesses?” he continued. “It’s the revenge of the hippies! Sex, drugs, and rock ‘n’ roll have come back to haunt us in a bad way!”

But the big question is – is Phil right or wrong? According to the CDC’s website, “Almost every sexually active person will acquire HPV [Human Papillomavirus] at some point in their lives.”

“Sexually active” would seem to indicate activity with new or multiple partners, rather than this Duck Doctor Phil’s Prescription.

But still – “Almost every…person.” That’s quite a few – the website also says, “about 79 million Americans are currently infected with HPV. About 14 million people become newly infected each year.” While it is the most prevalent venereal disease, HPV is only one of many.

Generally, HPV’s symptoms are more a painful nuisance than life-threatening – genital warts, often only appearing years after the initial infection. But there are also life-threatening illnesses such as cervical cancer, which HPV causes.

Much more frightening, however, is the specter of HIV/AIDS. According to the CDC, there are about 1.2 million people currently living with HIV, and as many as 50,000 new cases a year, with 63 to 66 percent of those being “MSM,” or “Men who have Sex with Men.” Sadly, the lion’s share of new HIV infections is found in the 13-24 age group; despite being 16 percent of the nation’s population, they account for 26 percent of all new infections, with 72 percent of those being young MSM. While HIV is treatable, there is still no cure.

Although HIV, as well as the current increase in syphilis and hepatitis, are primarily targeting homosexual males, heterosexuals with multiple partners are by no means off the hook. As well as HPV, herpes, drug-resistant gonorrhea and chlamydia are on the rise, as well. The year 2013 saw 1.4 million cases of chlamydia and 820,000 new cases of gonorrhea, and the CDC estimates that one person in every six in the U.S. between the ages of 14 and 49 has herpes.

Criticize Phil all you like, folks – he doesn’t mind. He’s only saying this because he cares.

Listen to him again: “I don’t want you to become ill. I don’t want you to come down with a debilitating disease. I don’t want you to die early.”

“And if you hate me because I told you that,” he said, “I told you, my love for you is not contingent on how you feel about me. I love you anyway. I don’t want you to see you die early or get sick. I’m trying to help you, for cryin’ out loud! America, if I didn’t care about you, why would I bring this up?”

From this CPAC attendee’s perspective, Phil’s speech was not only important from a physical health perspective, it also, along with that duct-taped Bible of his, reminds us of the words of Charles Spurgeon: “A Bible that’s falling apart usually belongs to someone who isn’t.”

Greg Rohrbough, J.D., has been director of government relations for the Meredith Advocacy Group since 2006.

Advertisement
Featured Image
CBC video screenshot
Steve Weatherbe

Former abortionist who failed to kill unborn baby hit with $1 million lawsuit: baby was born with hole in heart

Steve Weatherbe
By

OTTAWA, March 2, 2015 (LifeSiteNews.com) – An Ontario mother of a baby born by mistake is suing the former doctor who botched her abortion for $1 million for his “gross negligence” and “medical malpractice.”

Tania Brown already had four children when she went to Dr. Michel Prevost in Almonte, Ontario in early 2011 for a medical (or pharmaceutical) abortion to prevent a fifth, which her doctor had advised might have birth defects. Several months later she suspected Prevost’s one-two punch of methotrexate (a poison to kill the baby) and misoprostol (to expel the corpse a week later) had not worked. An ultrasound confirmed a beating heart.

Too late for an abortion now, she gave birth, in May, to a baby with “a smaller brain; he had a hole in his heart; he had something wrong with his palate.” She gave him up for adoption.

Click "like" if you are PRO-LIFE!

Dr. Prevost relinquished his medical licence earlier this month with the certainty that if he didn’t, the Ontario College of Physicians and Surgeons would expel him after an investigation found him “incompetent in his practice of obstetrics and gynecology.”  They looked into 28 abortion cases, two so badly “botched” that the babies survived.

Small wonder the whole business sent Brown into a “debilitating depression,” but her lawyer Ralph Lee told the CBC the case “brings up larger issues…the issue of a woman’s access to abortion.”

Basically, Prevost couldn’t get the dosages right. Methotrexate, MedicineNet.com warns, “has infrequently caused serious (sometimes fatal) side effects.” These include severe azotemia (too much blood urea nitrogen), severe blood infection, stomach and intestinal bleeding, and perforation.

Advertisement

Customize your experience.

Login with Facebook